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Le Palais des Congrès

Apr 13, 2015 9:00 AM - Apr 13, 2015 12:30 PM

2, Place de la porte Maillot, F-75017 Paris, France

EM02: INTERACTIONS BETWEEN REGULATORY AND INTELLECTUAL PROPERTY, PRODUCT LIABILITY AND DATA PRIVACY

Overview

Interactions between the regulatory regime and intellectual property (for example, SPC, data exclusivity), product liability (e.g., off-label information in summary of product characteristics (SmPC), competition (for example, public procurement) and privacy (e.g., clinical trials) rules are increasing. As a result, those matters can no longer be approached in isolation, and a more comprehensive perspective is required when addressing regulatory issues.

Who should attend?

The tutorial is designed for non-lawyers with good regulatory experience and for regulatory lawyers who want to learn the basics of intellectual property, competition, and product liability rules as they apply to the pharmaceutical sector

Learning objectives

At the conclusion of this tutorial, attendees will be able to:

  • Explain and discuss the basics of intellectual property, product liability and competition rules applicable to medicinal products
  • Identify and better address the regulatory issues that present an intellectual property, product liability or competition aspect

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